What documentation is required in the sub-folders for a full review

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Product Artwork

Product Declarations

Product Manual – Construction Details

Product Registrations

Product Testing

1. Product Artwork – Point-of-sale product artwork showing all artwork panels of the packaging and any printed supporting materials supplied with the product. Please only upload low-resolution product artwork as it is for identification purposes, either: pdf/jpeg/jpg/png/psd.

A copy of any instructions provided inside the point-of-sale packaging needs to be saved in this folder as well, to ensure a visual representation of all information supplied with the product (excluding shipping information) is present.

2. Product Declarations If your product has a market compliance marking requirement (e.g., UKCA or CE mark), then you have a mandatory requirement to hold on file either a self-declaration to a specified format or a declaration provided by a notified body depending on your product and legislation requirements. It is encouraged to hold a voluntary self-declaration even if a mandatory one is not required as it is good due diligence but also reinforces your technical competency and control over your product development if challenged.

3. Product Manual – Construction Details

• Bill of Materials (BoM): Provides a breakdown of the materials and volume involved in the construction of the product up to the point-of-sale packaging. It helps confirm that the current substantiation file addresses the product as a whole. This also aids in recording packaging waste for billing purposes and demonstrates control over product development.
• Specification: Maps out the construction requirements and tolerances, demonstrating the quality and consistency of your product development.
• Risk Assessments: Mandatory for certain product areas (e.g., toys) or voluntary recordings.
• Safety Data Sheets: Required for formulated products.
• Product Manuals: Includes printed manuals supplied with the product or online content (off-pack copy), such as online advertising or product write-ups.

4. Product Registrations

• 3rd party endorsements e.g., FSC certificate of sustainable wood/paper supplied, quality endorsement;
• Notified Body registrations e.g.: Organic for food; CPNP/SCPN registration for cosmetics, or national poison centre for formulated products
• Confirmation of Extended Producer Responsibility (EPR) registration requirements e.g., packaging waste.
• A record of any official registration requirements e.g. Green Dot, Recycling Schemes, Formulation Registrations (UFI), Help Line registrations

5. Product Testing

• Health and safety testing – mandatory;
• Any testing specified in the regulations and directives relating to your product.
• Voluntary test reports (e.g. performance testing) are encouraged to be filed as it demonstrates due diligence, but this is at your discretion.

Add the information as per the filing guidance. This ensures consistency across our filing and helps keep your review time and cost to a minimum. This information will also become your official legal representation of the product for your intended markets, so it is imperative it is in a clear logical format.

As a minimum CERT will need a copy of the product artwork to be used on the point-of-sale packaging (all faces of the packaging) and any technical documentation or testing to prove the safety and market compliance of your product. Information such as registration confirmation is recommended but not mandatory in all product areas. As a minimum we will require an internal declaration/email confirming your registration requirements e.g., packaging waste have been addressed. For example, if you sell electrical products on the German market with out a Waste Electronic and Electrical Equipment (WEEE) registration in place, it is subject to a €160k fine.

Please do not delete sub-folders if you believe they are not relevant. They are there for both of us as a reminder to consider if details are necessary. If the folder is blank when we review your product, the assumption will be made that you do not consider it not necessary to have any substantiation in that product area (which is common). Our regulatory professional team will feedback if you are missing information, but removal of folders slows down our review time and can incur extra cost.

It is at your discretion what information you would like assessed, but the more information you can provide, the more comprehensive evaluation we can provide. If inadequate information is provided for assessment and further details are declined upon request, CERT reserves the right to refrain from reviewing the product due to legal and safety considerations.

Next step – Update the Project Schedule and notify CERTLabel (see how in our Regulatory Review Guidance)